Long-term Treatment Study of CDP870 as Add-on Medication to MTX in Japanese Rheumatoid Arthritis (RA) Patients

This study has been completed.
Sponsor:
Collaborator:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00851318
First received: February 23, 2009
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

The objectives of this study is to evaluate the safety and efficacy of CDP870 as add-on medication to MTX over the long term in Japanese RA patients who are transferred from the Study 275-08-001, as well as to evaluate the effects of dosing regimens on the safety and efficacy of CDP870 in the ACR20 responders who completed Study 275-08-001.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: CDP870 200 mg
Drug: CDP870 400 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered in Combination With Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-001)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Adverse events [ Time Frame: At any time ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • American College of Rheumatology (ACR) 20/50/70 responder rate [ Time Frame: Week 24, 52 ] [ Designated as safety issue: Yes ]
  • Disease Activity Score (DAS) 28 (ESR) [ Time Frame: Week 24, 52 ] [ Designated as safety issue: Yes ]
  • Modified Total Sharp Score [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

Enrollment: 285
Study Start Date: March 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CDP870 200 mg
given every 2 weeks
Drug: CDP870 200 mg
Subcutaneous (SC)
Experimental: CDP870 400 mg
given every 4 weeks
Drug: CDP870 400 mg
SC

Detailed Description:

This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who participated in Study 275-08-001 and meet all of the criteria described below.

    • Patients who did not reach ACR20, and prematurely discontinued Study 275-08-001 at Week 16 or completed Study 275-08-001 by Week 24.
    • Patients who are able to receive treatment with MTX, by Week 52.

Exclusion Criteria:

  • Patients who experienced an important protocol deviation as mentioned below during Study 275-08-001.
  • Patients who received live or attenuated vaccines during Study 275-08-001(Except for influenza or pneumococcal vaccines).
  • Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-001.
  • Patients who required treatment for the same infection at two or more different times during Study 275-08-001
  • Women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.
  • Patients whom the investigator has decided to be inappropriate for participation in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851318

Locations
Japan
Chubu Region, Japan
Chugoku Region, Japan
Hokkaido Region, Japan
Kanto Region, Japan
Kinki Region, Japan
Kyushu Region, Japan
Shikoku Region, Japan
Tohoku Region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
UCB Japan Co. Ltd.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00851318     History of Changes
Other Study ID Numbers: CDP870-275-08-002, JapicCTI-090700
Study First Received: February 23, 2009
Last Updated: June 26, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:
Rheumatoid Arthritis
Certolizumab Pegol
Cimzia

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014